FDA requests withdrawal of weight-loss drug due to cancer risk
The FDA requested that the manufacturer of the serotonin receptor agonist lorcaserin voluntarily withdraw the weight-loss drug from the U.S. market because of clinical trial data that show an increased occurrence of cancer, according to an agency alert issued today.
The manufacturer, Eisai, has submitted a request to voluntarily withdraw lorcaserin (Belviq), according to the FDA.
This announcement comes on the heels of an FDA safety alert issued in January. As Healio previously reported, the FDA warned that results from a clinical trial assessing safety show a possible increased risk for cancer with lorcaserin. In a press release issued at that time, the FDA stated it could not conclude definitively that lorcaserin contributes to the cancer risk, and would communicate final conclusions and recommendations after completing an agency review.
Lorcaserin was approved by the FDA in 2012 for use with a reduced-calorie diet and increased physical activity to facilitate weight loss in adults with overweight or obesity and weight-related comorbidities. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet and an extended-release tablet (Belviq XR).
When lorcaserin was approved, the FDA required Eisai to conduct a clinical trial to evaluate cardiovascular risk, according to the safety communication issued today. The agency noted that a range of cancer types was reported, with pancreatic, colorectal and lung cancers occurring more frequently in the lorcaserin group.
Findings from the CAMELLIA-TIMI 61 trial, reported by Healio in 2018, demonstrated that treatment with lorcaserin yielded sustained weight loss during a median follow-up of 3 years without excess risk for major adverse CV events among adults with overweight or obesity at high CV risk. In the randomized, double-blind, placebo-controlled trial of more than 12,000 patients with atherosclerotic CVD or multiple CV risk factors, researchers also found no increased risk for new or worsening valvulopathy among patients assigned lorcaserin compared with placebo.
In CAMELLIA-TIMI 61, more patients assigned lorcaserin were diagnosed with cancer compared with patients taking placebo, the FDA stated.
“Our evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer,” the FDA stated in the release.
The FDA stated that health care professionals should stop prescribing and dispensing lorcaserin to patients, and should inform patients currently taking lorcaserin of the increased risk for cancer seen in the clinical trial and should ask them to stop taking lorcaserin.
At this time, the FDA is not recommending special screening for patients who have taken lorcaserin. – by Regina Schaffer